MAUDE Adverse Event Report: 4F TEMPO 0.038" 65CM VERTEBRAL; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SRD5821

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot# 17946132 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 4f 65cm 0.038¿ tempo catheter was inserted, and two non-cordis interlocks were implanted.However, there was an intensive resistance felt when it was released.The physician noticed that the junction between the tip and the catheter was split.Some tornado coils were implanted, and the interlocks were inserted again.The physician attempted to implant it, but it was not able to detach.They were removed and replaced with other non-cordis interlock, but the same issue occurred again.It was implanted but there were abnormalities when it was detached.After coil embolization, the tempo catheter was removed from the 5f non-cordis sheath introducer.There was no reported patient injury.The lesion was the left subclavian artery.The procedure was a coil embolization.A 6f non-cordis sheath introducer, a non-cordis 0.035 inches 180 cm guidewire, a non-cordis interlock coil and a non-cordis tornado coil were used together.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly g4,g7,h1,h2,h3 and h6.As reported, a 4f 65cm 0.038¿ tempo catheter was inserted, and two non-cordis interlocks were implanted.However, there was an intensive resistance felt when it was released.The physician noticed that the junction between the tip and the catheter was split.Some tornado coils were implanted, and the interlocks were inserted again.The physician attempted to implant it, but it was not able to detach.They were removed and replaced with other non-cordis interlock, but the same issue occurred again.It was implanted but there were abnormalities when it was detached.After coil embolization, the tempo catheter was removed from the 5f non-cordis sheath introducer.There was no reported patient injury.The lesion was the left subclavian artery.The procedure was a coil embolization.A 6f non-cordis sheath introducer, a non-cordis 0.035 inches 180 cm guidewire, a non-cordis interlock coil and a non-cordis tornado coil were used together.A non-sterile unit of a tempo diagnostic cathter (4f tempo 0.038" 65cm vertebral) was received for analysis.Per visual analysis, a kinked/bent condition was observed located at 12 cm from the hub edge.Also, a frayed/split/torn condition was noticed at the brite tip.No other damages or anomalies were observed.The functional test was not performed due to the damage observed on the brite tip.Dimensional analysis was performed to verify the correct guiding catheter outer diameter (od).Measurements were taken near the damage, and in the middle and proximal sections.Dimensional analysis results were found within specification.Per microscopic analysis, the torn damage presents a path direction from the inside of the body to the outside.The torn area presented evidence of elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the damage.No other issues were noted during microscopic analysis.A product history record (phr) review of lot 17946132 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event the complaint reported by the customer as ¿catheter (body/shaft) - resistance/friction in patient ¿ was not confirmed as the functional analysis could not be performed due to the damage on the distal tip of the returned device and the dimensional analysis results were found within specification.The complaint reported by the customer as ¿brite tip/distal tip catheters - frayed/split/torn in patient¿ was confirmed, a frayed/split/torn condition was noticed on the brite tip.The torn area presented evidence of elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the damage.Vessel characteristics, although not provided, and/or procedural/handling factors might have contributed to the reported events.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters; straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.¿ neither the phr review nor the product analysis suggest that the reported conditions could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 4F TEMPO 0.038" 65CM VERTEBRAL
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10636077
• MDR Text Key: 210369209
• Report Number: 9616099-2020-03953
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032049143
• UDI-Public: 20705032049143
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: SRD5821
• Device Catalogue Number: SRD5821
• Device Lot Number: 17946132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (0.035 INCHES 180 CM RADIFOCUS, TERUMO).; INTERLOCK COIL(S) (BOSTON SCIENTIFIC); INTRODUCER (6FR H, TERUMO).; TORNADO COIL(S) (COOK)